SESSION TITLE: Diffuse Lung Disease Poster Discussions
SESSION TYPE: Original Investigation Poster Discussion
PRESENTED ON: Wednesday, October 28, 2015 at 02:45 PM - 04:00 PM
PURPOSE: There are limited data on the health-related quality of life (HRQL) of patients with IPF and the impact of treatment on this outcome. We evaluated the psychometric properties of the St George’s Respiratory Questionnaire (SGRQ), originally developed for use in patients with obstructive lung disease, using pooled data from the two replicate Phase III INPULSIS® trials of nintedanib in patients with IPF.
METHODS: Data from all patients treated with nintedanib or placebo were pooled. Construct validity was assessed by evaluating the relationship between SGRQ total and domain scores and the Cough and Sputum Assessment Questionnaire (CASA-Q) cough domains, University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ), EuroQol 5-Dimensional Quality of Life Questionnaire visual analogue scale (EQ-5D VAS), and forced vital capacity (FVC) % predicted. Construct validity was assessed cross-sectionally at baseline and longitudinally as change from baseline to week 52. Distribution- and anchor-based approaches (using FVC % predicted, UCSD-SOBQ and Patient’s Global Impression of Change [PGI-C] as anchors) were used to estimate a clinically meaningful change in SGRQ score from baseline to week 52.
RESULTS: 1061 patients were treated in the INPULSIS® trials. Moderate to strong, statistically significant cross-sectional correlations were observed between the SGRQ total and domain scores and CASA-Q cough domains (−0.34 to −0.65), UCSD-SOBQ (0.56 to 0.83) and EQ-5D VAS (−0.41 to −0.55); correlations with FVC % predicted were weak (−0.24 to −0.30). Longitudinal correlations between SGRQ total score and these measures were moderate and statistically significant. With FVC % predicted as the anchor, changes in SGRQ total score of 4 to 5 points over 52 weeks represented meaningful improvement or deterioration; with UCSD-SOBQ as the anchor, changes of 3 to 11 and 2 to 8 points represented meaningful deterioration and improvement, respectively; and with PGI-C as the anchor, changes of 10 and 0 points represented meaningful deterioration and improvement, respectively. Using a distribution-based approach, a change of 4 to 11 points was meaningful.
CONCLUSIONS: The SGRQ demonstrated appropriate construct validity in patients with IPF treated in the INPULSIS® trials. Anchor- and distribution-based approaches suggested a change of 4 to 10 points over 52 weeks to be clinically meaningful.
CLINICAL IMPLICATIONS: The SGRQ is an acceptable patient-reported outcome measure for evaluating aspects of HRQL in patients with IPF.
DISCLOSURE: Jeffrey Swigris: Consultant fee, speaker bureau, advisory committee, etc.: Jeffrey Swigris has served as a paid consultant for Boehringer Ingelheim Hilary Wilson: Other: Hilary Wilson is employed by Evidera. Evidera has been paid by Boehringer Ingelheim for its contribution to research presented in certain publications. Dirk Esser: Employee: Dirk Esser is an employee of Boehringer Ingelheim Craig Conoscenti: Employee: Craig Conoscenti is an employee of Boehringer Ingelheim Wibke Stansen: Employee: Wibke Stansen is an employee of Boehringer Ingelheim Nancy Leidy: Other: Nancy Leidy is employed by Evidera. Evidera has been paid by Boehringer Ingelheim for its contribution to research presented in certain publications. Kevin Brown: Consultant fee, speaker bureau, advisory committee, etc.: Kevin Brown has served as a paid consultant for Boehringer Ingelheim
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